EU MDR/IVDR
Expert Panels: Functions and Features According to the new regulatory framework set forth by Medical Device Directive (MDR) and In Vitro Diagnostic Directive (IVDR), special expert panels should be designated to provide assistance to regulating authorities and...
EU MDR/IVDR
British medical products regulating authority, the MHRA, issued a special guidance describing the impact Brexit could have on medical device regulations. The guidance describes the consequences of Brexit to all parties involved in medical device development,...
EU MDR/IVDR
Danish Medicines Agency (DKMA) announced that they would provide special consultation on the requirements set forth by Medical Device Regulation (MDR 745/2017). These consultations are intended for small and medium size medical device manufacturers who face issues...
EU MDR/IVDR
All medical device manufacturers should be aware that the last CE certificate renewal deadline expires later this month. Those who miss it could face regulatory issues, delays, and additional expenses. CE Certificate Renewal Requirements According to the...
EU MDR/IVDR
The adoption of Medical Device Regulation is a new step towards the improvement of the medical device regulatory framework. Regulation 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (or the MDR) replaces the Medical Device...
EU MDR/IVDR
According to the MDR requirements, Notified Bodies (NB) should be designated to maintain operations connected with the registration process and perform other supervisory actions. In the course of these medical device regulations, the Spanish regulating authority, the...
